CERDELGA 84 mg Hard Capsule

Содержание инструкции

1. Cerdelga 21 mg hard capsules, 84 mg hard capsules
   1. What is Cerdelga and what is it used for
   2. What you need to know before taking Cerdelga
   3. How to take Cerdelga
   4. Possible side effects
   5. How to store Cerdelga
   6. Contents of the pack and other information

Cerdelga 21 mg hard capsules, 84 mg hard capsules

eliglustat

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Cerdelga is and what it is used for
• 2. What you need to know before you take Cerdelga
• 3. How to take Cerdelga
• 4. Possible side effects
• 5. How to store Cerdelga
• 6. Contents of the pack and other information

1. What is Cerdelga and what is it used for

Cerdelga contains the active substance eliglustat and is used for the long-term treatment of adult and children patients aged 6 years and over who weigh at least 15 kg with type 1 Gaucher disease.
When used in children, Cerdelga is indicated for those children whose disease is under control using enzyme replacement therapy. Your doctor will determine if Cerdelga is suitable for you or your child before starting to take it, using a simple laboratory test.
Type 1 Gaucher disease is a rare inherited condition in which a substance called glucosylceramide is not broken down effectively by the body. As a result, glucosylceramide accumulates in the spleen, liver and bones, preventing these organs from functioning properly. Cerdelga contains the active ingredient eliglustat, which decreases the production of glucosylceramide, thus preventing its accumulation and helping the affected organs to function better.
The medicine is broken down by the body at different rates in different people. Consequently, the amount of medicine in the blood may differ between patients, which can influence how a patient responds. Cerdelga must be used in patients whose body breaks down the drug at a normal rate (known as intermediate metabolizers and extensive metabolizers) or at a slow rate (known as poor metabolizers).
Type 1 Gaucher disease is a chronic condition and you must continue to take the medicine as prescribed by your doctor to obtain the maximum benefit.

2. What you need to know before taking Cerdelga

Do not take Cerdelga

• If you are allergic to eliglustat or any of the other ingredients of this medicine (listed in section 6).
• If you are an intermediate or extensive metabolizer (metabolize Cerdelga at an intermediate or high rate) and are using medicines known as strong or moderate CYP2D6 inhibitors (such as quinidine and terbinafine) in combination with strong or moderate CYP3A inhibitors (such as erythromycin and itraconazole). The combination of these medicines interferes with the body's ability to break down Cerdelga and consequently may determine higher levels of the active ingredient in the blood (for a complete list of medicines see the section “Other medicines and Cerdelga”).
• If you are a poor metabolizer (metabolize Cerdelga at a low rate) and are using medicines known as strong CYP3A inhibitors (such as itraconazole). These types of drugs interfere with the body's ability to metabolize Cerdelga and this may result in higher levels of the active ingredient in the blood (for a complete list of medicines see the section “Other medicines and Cerdelga”).
• If you are an extensive metabolizer (metabolize Cerdelga at a high rate) and have severely reduced liver function.
• If you are an extensive metabolizer (metabolize Cerdelga at a high rate) and have mild or moderate liver impairment and are taking a strong or moderate CYP2D6 inhibitor at the same time.

Warnings and precautions
Talk to your doctor or pharmacist before taking Cerdelga if:

• you are currently taking or are about to start taking any of the medicines listed in the section “Other medicines and Cerdelga” .
• You have had a heart attack or heart failure.
• You have a slow heartbeat.
• You have an irregular or abnormal heartbeat, including a condition called long QT syndrome.
• You have other heart problems.
• You are taking antiarrhythmic medicines (used to treat irregular heartbeat) such as quinidine, amiodarone or sotalol.
• If you are an extensive metabolizer (metabolize Cerdelga at a high rate) and have moderately impaired liver function.
• If you are an intermediate or poor metabolizer (metabolize Cerdelga at an intermediate or low rate) and have impaired liver function of any degree.
• If you are an intermediate or poor metabolizer (metabolize Cerdelga at an intermediate or low rate) and have impaired kidney function.
• If you are a patient with end-stage renal disease.

Children and adolescents
Cerdelga should not be used in children under 6 years of age or weighing less than 15 kg.

Other medicines and Cerdelga
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.

Medicines that must not be taken together with Cerdelga
Cerdelga must not be taken with certain types of medicines. These medicines can interfere
with the body's ability to break down Cerdelga, resulting in consequently higher levels of
Cerdelga in the blood. These medicines are known as strong or moderate CYP2D6 inhibitors and
strong or moderate CYP3A inhibitors. There are many medicines in these categories and, depending on how
the body metabolizes Cerdelga, the effects may be different from person to person. You must
discuss these medicines with your doctor before starting to take Cerdelga. The
doctor will determine which medicines you can use based on the rate at which your body
metabolizes eliglustat.

Medicines that can increase the level of Cerdelga in the blood, such as:

• paroxetine, fluoxetine, fluvoxamine, duloxetine, bupropion, moclobemide - antidepressants(used to treat depression)
• dronedarone, quinidine, verapamil - antiarrhythmic drugs(used to treat irregular heartbeat)
• ciprofloxacin, clarithromycin, erythromycin, telithromycin - antibiotics(used to treat infections)
• terbinafine, itraconazole, fluconazole, posaconazole, voriconazole - antifungals(used to treat fungal infections)
• mirabegron - used to treat overactive bladder
• cinacalcet - calcimimetic(used in some patients on dialysis and in certain types of cancer)
• atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, ritonavir, saquinavir, tipranavir - antiretrovirals(used to treat HIV)
• cobicistat - used to improve the effects of antiretrovirals (used to treat HIV)
• aprepitant - antiemetic(used to reduce vomiting)
• diltiazem - antihypertensive(used to increase blood flow and decrease heart rate)
• conivaptan - diuretic(used to increase low sodium levels in the blood)
• boceprevir, telaprevir - antiviral(used to treat hepatitis C)
• imatinib - anticancer drug(used to treat cancer)
• amlodipine, ranolazine - used to treat angina pectoris
• cilostazol - used to treat leg cramps when walking caused by insufficient blood flow to the legs
• isoniazid - used to treat tuberculosis
• cimetidine, ranitidine - antacids(used to treat indigestion)
• hydrastis (Goldenseal - also known as Hydrastis canadensis) an over-the-counter herbal preparation, used as a digestive aid.

Medicines that can decrease the level of Cerdelga in the blood:

• rifampicin, rifabutin - antibiotics(used to treat infections)
• carbamazepine, phenobarbital, phenytoin - antiepileptics(used to treat epilepsy and seizures)
• St. John's wort - (also known as Hypericum perforatum) an over-the-counter herbal preparation, used to treat depressionand other conditions

Cerdelga can increase the level in the blood of the following types of medicines:

• dabigatran - anticoagulant(used to thin the blood)
• phenytoin - antiepileptic(used to treat epilepsy and seizures)
• nortriptyline, amitriptyline, imipramine, desipramine - antidepressants(used to treat depression)
• phenothiazines - antipsychotics(used to treat schizophrenia and psychosis)
• digoxin - used to treat heart failure and atrial fibrillation
• colchicine - used to treat gout
• metoprolol -used to lower blood pressure and/or heart rate
• dextromethorphan - cough medicine
• atomoxetine - used to treat attention deficit hyperactivity disorder (ADHD)
• pravastatin - used to lower cholesterol and prevent heart disease

Cerdelga with food and drink
Avoid consuming grapefruit or grapefruit juice, as they can increase the level of
Cerdelga in the blood.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor
who will discuss with you whether to take this medicine during pregnancy.
The active ingredient contained in this medicine has been shown to pass in trace amounts into breast milk
in animals. Breastfeeding is not recommended during treatment with this
medicine. Tell your doctor if you are breastfeeding.
There are no known effects on fertility at normal doses.

Driving and using machines
Cerdelga may affect your ability to drive and operate machinery in patients who
experience dizziness after administration.

Cerdelga contains lactose
If your doctor has told you that you are intolerant to certain sugars, talk to your doctor before
taking this medicine.

3. How to take Cerdelga

Take this medicine exactly as your doctor or pharmacist has told you. If you
have any doubts, ask your doctor or pharmacist.
Cerdelga is available in 2 different dosages. The hard capsules containing 84 mg of eliglustat are blue
green and white and the hard capsules containing 21 mg of eliglustat are completely white.
When giving this medicine to your child, make sure they are taking the right dose.
Cerdelga must be taken orally in children who can swallow the capsule whole.
The Cerdelga hard capsules must be swallowed whole with water at the same time each day. It may
be taken with or without food. Those taking the dose twice a day should take
one dose in the morning and one dose in the evening.
Do not open, crush, dissolve, or chew the hard capsule before swallowing it. If you cannot
swallow the capsule whole, tell your doctor.
Mixing the contents of the capsule (eliglustat powder) into food or beverages has not
been studied.

Recommended dose for adults
If you are an intermediate metabolizer or an extensive metabolizer:
Swallow one 84 mg capsule whole twice a day with water. The capsules can be
taken during or away from meals. Take one capsule in the morning and one capsule in the evening.
If you are a slow metabolizer:
Swallow one 84 mg capsule whole once a day with water. The capsules can be
taken during or away from meals. Take one capsule at the same time each day.
Do not open, crush, dissolve, or chew the capsules before swallowing them. If you cannot swallow the
capsules whole, talk to your doctor.

Recommended dose for children
The amount of this medicine that your child needs to take depends on their body weight and
how they metabolize the medicine. Your doctor will determine this before starting treatment.
Continue to take Cerdelga every day for the period indicated by your doctor.

How to dispense the 21 mg hard capsules
Break the foil covering the capsule using your thumb or index finger and push the capsule outwards.

How to remove the blister pack from the housing for the 84 mg hard capsules
Pressing one end of the housing with your thumb and index finger (1), gently pull
out the blister pack to open the housing (2).

If you take more Cerdelga than you should
If you take more capsules than prescribed, contact your doctor immediately. You may experience
dizziness accompanied by loss of balance, slow heartbeat, nausea, vomiting, and lightheadedness.

If you forget to take Cerdelga
Take the next capsule at your usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Cerdelga
Do not stop taking Cerdelga without telling your doctor.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common(may affect up to 1 in 10 people):

• Headache
• Dizziness
• Taste alteration (dysgeusia)
• Palpitations
• Throat irritation
• Cough
• Heartburn (dyspepsia)
• Stomach pain (pain in the upper abdomen)
• Diarrhoea
• Feeling unwell (nausea)
• Constipation
• Abdominal pain
• Acid reflux disease (gastro-oesophageal reflux disease)
• Bloating (abdominal distension)
• Inflammation of the stomach (gastritis)
• Difficulty swallowing (dysphagia)
• Vomiting
• Dry mouth
• Gas (flatulence)
• Dry skin
• Urticaria
• Joint pain (arthralgia)
• Pain in arms, legs or back
• Tiredness (fatigue)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Cerdelga

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, the container and the blister
after “EXP / Scad.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cerdelga contains
The active ingredient is eliglustat (as tartrate).
Cerdelga 21 mg hard capsules:
Each hard capsule contains 21 mg of eliglustat
The other ingredients are:
o In the capsule: cellulose, microcrystalline (E460), lactose monohydrate (see section 2
“Cerdelga contains lactose”), hypromellose 15 mPa.S, 2910 and glyceryl dibehenate.
o In the capsule coating: gelatin (E441), potassium aluminium silicate (E555),
titanium dioxide (E171)
o In the printing ink: shellac, black iron oxide (E172), propylene glycol
(E1520) and ammonia solution, concentrated (E527).
Cerdelga 84 mg hard capsules:
Each hard capsule contains 84 mg of eliglustat
The other ingredients are:
o In the capsule: cellulose, microcrystalline (E460), lactose monohydrate (see section 2
“Cerdelga contains lactose”), hypromellose and glyceryl dibehenate.
o In the capsule coating: gelatin (E441), potassium aluminium silicate (E555),
titanium dioxide (E171), yellow iron oxide (E172) and indigotine (E132).
o In the printing ink: shellac, black iron oxide (E172), propylene glycol
(E1520) and ammonia solution, concentrated (E527).

Description of the appearance of Cerdelga and contents of the pack
Cerdelga 21 mg hard capsules:
Cerdelga 21 mg hard capsules: have an opaque white cap and a pearly white body
with the inscription “GZ04” printed in black ink on the capsule.
Pack of 56 hard capsules in 4 blisters of 14 capsules each.
Cerdelga 84 mg hard capsules:
Cerdelga 84 mg hard capsules have an opaque bluish-green cap and an opaque
pearly white body with the inscription “GZ02” printed in black ink on the capsule.
Packs of 14 hard capsules in 1 blister pack, 56 hard capsules in 4 blister packs of
14 capsules each or 196 hard capsules in 14 blister packs of 14 capsules each.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sanofi BV
Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Manufacturer
Cerdelga 21 mg hard capsules
Patheon France
40 Boulevard de Champaret
Bourgoin Jallieu
38300
France
Cerdelga 84 mg hard capsules
Sanofi Winthrop Industrie
30-36 avenue Gustave Eiffel
37100 Tours
France
Sanofi Winthrop Industrie
1 rue de la Vierge
Ambares et Lagrave
33565 Carbon Blanc cedex
France
Genzyme Ireland Ltd
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien/
Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: + 32 2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Magyarország
SANOFI-AVENTIS Zrt.
Tel: +36 1 505 0050

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Danmark
Sanofi A/S
Tlf.: +45 45 16 70 00

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel.: 0800 04 36 996
Tel. aus dem Ausland: +49 69 305 70 13

Norge
sanofi-aventis Norge AS
Tlf: + 47 67 10 71 00

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Österreich
sanofi-aventis GmbH
Tel: + 43 1 80 185 - 0

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 1600

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Portugal
Sanofi – Produtos Farmacêuticos, Lda. Tel:
+351 21 35 89 400

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

HrvatskaSlovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ireland
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Ísland
Vistor hf.
Sími: +354 535 7000

Suomi/Finland
Sanofi Oy
Puh/Tel: + 358 201 200 300

Italia
Sanofi S.r.l.
Tel: 800 536 389

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

Altre fonti d’informazioni
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu. In addition, links to other websites on rare diseases
and related therapeutic treatments are provided.